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Drotrecogin Alfa (activated) Improves In-hospital and 90-day Survival in Patients With Severe Sepsis and Community-acquired Pneumonia FREE TO VIEW

Richard G. Wunderink, MD, FCCP; Sachin Yende, MD; Pierre-Francois Laterre, MD; David E. Joyce, MD; Becky Bates, MS; Howard Levy, MBBCh
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Methodist Healthcare, Memphis, TN


Chest


Chest. 2003;124(4_MeetingAbstracts):91S. doi:10.1378/chest.124.5.1789
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Abstract

PURPOSE:  Community acquired pneumonia (CAP) was reported in 35.6% of patients enrolled in a phase III trial of drotrecogin alfa (activated) in severe sepsis (PROWESS). 28 days following infusion, the relative risk reduction (RRR) in CAP was 27.8% (p = 0.015). We report in-hospital and 90-day survival for patients with CAP including Streptococcus pneumoniae.

METHODS:  CAP was defined as: (1) lung identified as primary site of infection as determined by a blinded clinical evaluation committee (CEC) (2) admission to hospital from home, and (3) receipt of study drug within 4 days of hospital admission. The CEC also adjudicated causative microorganism(s) responsible for severe sepsis in each patient. Mortality relative risk estimates with 95% confidence intervals (CIs) were calculated for each subgroup.

RESULTS:  In the overall PROWESS population, treatment with drotrecogin alfa (activated) yielded a 19.4% adjusted RRR in all-cause mortality at day 28, p=0.005. Of the 602 patients with any CAP, 46% received placebo and 54% received drotrecogin alfa (activated). Hospital mortality for CAP was 27.0% for drotrecogin alfa (activated) and 35.4% for placebo, an absolute risk reduction of 8.4% and a RRR of 23.8% (relative risk = 0.762, 95% CI = 0.598 – 0.971). At 90 days, mortality for CAP was 33.8% for drotrecogin alfa (activated) and 39.5% for placebo (RRR = 14.4%, relative risk = 0.856, 95% CI = 0.688 – 1.065). Of the 157 patients with CAP due to S. pneumoniae, 52% received placebo and 48% received drotrecogin alfa (activated). In the S. pneumoniae subgroup, hospital and 90-day mortality rates for drotrecogin alfa (activated) were 26.4% and 31.8% and for placebo 37.5% and 38.8%, respectively. RRR for patients with S. pneumoniae was 29.6% in hospital and 17.9% at 90 days.CONCLUSIONS: The survival benefit associated with drotrecogin alfa (activated) is maintained 28 to 90 days after treatment for any CAP including S. pneumoniae.CLINICAL IMPLICATION: A long-term survival benefit in CAP from drotrecogin alfa (activated) was similar to the overall PROWESS trial.

DISCLOSURE:  R.G. Wunderink, Eli Lilly and Company, Discussion of product research or unlabeled uses of Product.

Monday, October 27, 2003

2:30 PM - 4:00 PM


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